| CTRI Number |
CTRI/2025/05/086633 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti-Pigmentation activity of Vitamin-C Moisturizer |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Anti-Pigmentation activity of Vitamin-C Moisturizer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT636 Version 1.0 dated 29 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
|
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, UTTAR PRADESH, 250005-India |
| Pureplay Skin Sciences (I) Pvt Ltd, 1st Floor, Lodha i-Think Techno Campus, A Wing, Chirak Nagar, Thane, Maharashtra, India - 400607
|
|
|
Primary Sponsor
|
| Name |
Pureplay Skin Science Pvt Ltd |
| Address |
1st Floor, Lodha i-Think Techno Campus, A Wing, Chirak Nagar, Thane, Maharashtra, India - 400607 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
9027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Vitamin-C Moiusturizer |
Test Product: Vitamin-c Moisturizer
Dose: :1 gm twice in a day
Route of Administration: Topical, Duration: 28 Days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Non-pregnant, non-lactating female aged between18 to
50.
2. Subject with Pigmentation.
3. Subject willing to give written informed consent
4. Women of child bearing potential must have a negative urine
pregnancy test
5. Free of any systemic and dermatologic disorder, which in the
opinion of the investigator, will interface with the study results
or increase the risk of AE.
6. Are willing to avoid prolonged exposure of the treatment area to
ultraviolet radiation (natural or artificial) for the duration of the
study |
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast feeding, or planning to
become pregnant during the study
2. Volunteers with skin conditions such as eczema, psoriasis,etc
3. Have any evidence of systematic cancer, squamous cell
carcinoma, basal cell carcinoma in the last 5 years, or any other
confounding skin condition.
4. Have open sore or open lesions in the treatment area
5. Have any condition that, in the opinion of the investigator,
would confound the safety and efficacy assessments of the
product.
6. Have participated in any interventional clinical trial in the
previous 30 days.
7. Have a known sensitivity to any of the constituents of the test
product including sensitivities to any of the constituents.
8. Have used, are using, or are planning to use immunosuppressive
or immunomodulatory medications (i.e., biologics), including
corticosteroids.
9. Have a history of alcohol or illegal drug/ substance abuse or
suspected alcohol or illegal drug/substance abuse in the past 2
years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Dark spots & Pigmentation
2. Change in Wrinkle count
3. Change in skin gloss
4. Change in Melanin Index
5. Change in skin lightness
6. Change in skin Hydration and TEWL |
At T0, T14 and T28Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A single blind one arm study. Each participant entering the trial will be assigned to a regimen of
investigational product.
Day 0 (T0) - Baseline Measurements: 1. Skin Gloss (Glossymeter): (0, 14, 28 days) 2. Skin Hydration (Corneometer): (T0, 30min, 14, 28 days) 3. TEWL (Tewameter): (0, 14, 28 days) 4. Skin Pigmentation (Melanin Index) (Mexameter): (0, 14, 28 days) 5. Dark Spots (Visioface): (0, 14, 28 days) 6. Skin Color (Chromameter): (0, 14, 28 days) 7. HD Imaging with DSLR: (0, 28 days) 8. Visioscan Imaging: (0, 28 days)
Dedicated Questionnaire (CRF) 1. Light weight 2. Quick Absorbing 3. Non-Irritant 4. Non-Sticky 5. Non-Greasy |